- Approval Id
- 8284c33a5cc945d9
- Drug Approval Emc Name
- E45 Itch Relief Cream
- Drug Name
- E45 Itch Relief Cream
- Company Name
- Karo Pharma AB
- Company Address
- Klara Norra Kyrkogata 33, Stockholm, Sweden
- Company Website
- https://www.karopharma.com/
- Company Telephone
- +44 (0) 8000461977
- Company Medical Info Direct Line
- +44 (0) 8000461977
- Company Medical Info Email
- MedinfoUK@karopharma.com
- Company Customer Care Direct Line
- +44 (0) 8000461977
- Atc Code
- D04AX
- Legal Category
- General Sales List
- Authorisation Holder
- Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
- Authorisation Number
- PL 50567/0013
- Authorisation Date
- 19 October 1999
- Instruction Authorisation Holder
- Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
- Instruction Authorisation Number
- PL 50567/0013
- Instruction Authorisation Date
- 19 October 1999
- Instruction Composition
- | | |
| --- | --- |
| Active ingredient | Percentage (w/w) |
| Lauromacrogols | 3.0 % |
| Urea | 5.0% |
- Instruction Dosage Form
- Cream
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults:\*\*
E45 Itch Relief Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response.
\*\*Elderly:\*\*
There is no indication that the dosage needs to be modified for the elderly.
\*\*Paediatric Populations\*\*
\*\*Children and infants over the age of 1 month:\*\*
There is no indication that the dosage needs to be modified for children or babies.
\*\*Method of administration\*\*
Topical application to the skin.4.3 Contraindications
Patients with known hypersensitivity lauromacrogols, urea or to any of the excipients listed in section 6.1. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.4.4 Special warnings and precautions for use
E45 Itch Relief Cream may cause irritation if applied to broken or inflamed skin.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
Urea may increase penetration through the skin barrier of other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil) when used at the same time.4.6 Pregnancy and lactation
There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
Adverse events which have been associated with urea; lauromacrogols are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivity |
| Skin and Subcutaneous Tissue Disorders | Not known | Application site pustules; skin burning sensation; pruritus; erythema |
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Overdose is very unlikely with a topical cream.
If overdose is suspected in young children or babies, seek the advice of a healthcare professional, since blood-urea concentrations may increase.
\*\*Management\*\*
In the unlikely event of an overdose, treatment should be symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group\*\*: Antipruritics, Incl. Antihistamines, Anaesthetics, etc.; Other Antipruritics;
\*\*ATC Code\*\*: D04AX
Urea is a physiological product derived from human protein metabolism. It is found naturally in the skin and when applied topically it can increase the horny layer's capacity to retain water. E45 Itch Relief Cream has been shown to increase skin hydration and when used as recommended provides hydration for 24 hours. Patients with eczema and psoriasis have been shown to have decreased levels of urea in their skin. Urea is not allergenic and is well- tolerated at a concentration of 5%.
Lauromacrogols have the properties of a topical anaesthetic and have an antipruritic effect. The local tolerability of lauromacrogols is good.
E45 Itch Relief Cream has also been shown to increase the lipid content of the epidermis thus, soothing and smoothing the skin.5.2 Pharmacokinetic properties
Little urea is absorbed after topical application. It is mainly excreted in the urine, and to a lesser extent in perspiration.
There is no evidence of systemic availability of lauromacrogols after topical administration.5.3 Preclinical safety data
No specific studies have been performed with E45 Itch Relief Cream. Urea and lauromacrogols have been used therapeutically for many years in humans. Information from animal studies are unlikely to provide any further relevant information.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Dimeticone, phenyl dimeticone, liquid paraffin, cetyl palmitate, stearic palmitic acid, octyldodecanol, glycerol 85%, polysorbate, carbomer, trometamol, benzyl alcohol, purified water.6.2 Incompatibilities
Not applicable.6.3 Shelf life
24 months6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Aluminium tubes with double internal lacquer of epoxy phenol resin and closure made of polyoxyethylene. Content: 10g, 35g, 50g, 60g, 75g, 100g and 110g.
Plastic pump dispensers. Content: 175g, 200g and 500g.
A pump pack, made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g
Not all pack sizes are necessarily marketed.6.6 Special precautions for disposal and other handling
None stated.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredient | Percentage (w/w) |
| Lauromacrogols | 3.0 % |
| Urea | 5.0% |
## Pharmaceutical Form
Cream
## Clinical Particulars
4.1 Therapeutic indications
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults:\*\*
E45 Itch Relief Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response.
\*\*Elderly:\*\*
There is no indication that the dosage needs to be modified for the elderly.
\*\*Paediatric Populations\*\*
\*\*Children and infants over the age of 1 month:\*\*
There is no indication that the dosage needs to be modified for children or babies.
\*\*Method of administration\*\*
Topical application to the skin.4.3 Contraindications
Patients with known hypersensitivity lauromacrogols, urea or to any of the excipients listed in section 6.1. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.4.4 Special warnings and precautions for use
E45 Itch Relief Cream may cause irritation if applied to broken or inflamed skin.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
Urea may increase penetration through the skin barrier of other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil) when used at the same time.4.6 Pregnancy and lactation
There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
Adverse events which have been associated with urea; lauromacrogols are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune System Disorders | Not known | Hypersensitivity |
| Skin and Subcutaneous Tissue Disorders | Not known | Application site pustules; skin burning sensation; pruritus; erythema |
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Overdose is very unlikely with a topical cream.
If overdose is suspected in young children or babies, seek the advice of a healthcare professional, since blood-urea concentrations may increase.
\*\*Management\*\*
In the unlikely event of an overdose, treatment should be symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group\*\*: Antipruritics, Incl. Antihistamines, Anaesthetics, etc.; Other Antipruritics;
\*\*ATC Code\*\*: D04AX
Urea is a physiological product derived from human protein metabolism. It is found naturally in the skin and when applied topically it can increase the horny layer's capacity to retain water. E45 Itch Relief Cream has been shown to increase skin hydration and when used as recommended provides hydration for 24 hours. Patients with eczema and psoriasis have been shown to have decreased levels of urea in their skin. Urea is not allergenic and is well- tolerated at a concentration of 5%.
Lauromacrogols have the properties of a topical anaesthetic and have an antipruritic effect. The local tolerability of lauromacrogols is good.
E45 Itch Relief Cream has also been shown to increase the lipid content of the epidermis thus, soothing and smoothing the skin.5.2 Pharmacokinetic properties
Little urea is absorbed after topical application. It is mainly excreted in the urine, and to a lesser extent in perspiration.
There is no evidence of systemic availability of lauromacrogols after topical administration.5.3 Preclinical safety data
No specific studies have been performed with E45 Itch Relief Cream. Urea and lauromacrogols have been used therapeutically for many years in humans. Information from animal studies are unlikely to provide any further relevant information.
## Pharmaceutical Particulars
6.1 List of excipients
Dimeticone, phenyl dimeticone, liquid paraffin, cetyl palmitate, stearic palmitic acid, octyldodecanol, glycerol 85%, polysorbate, carbomer, trometamol, benzyl alcohol, purified water.6.2 Incompatibilities
Not applicable.6.3 Shelf life
24 months6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Aluminium tubes with double internal lacquer of epoxy phenol resin and closure made of polyoxyethylene. Content: 10g, 35g, 50g, 60g, 75g, 100g and 110g.
Plastic pump dispensers. Content: 175g, 200g and 500g.
A pump pack, made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g
Not all pack sizes are necessarily marketed.6.6 Special precautions for disposal and other handling
None stated.
